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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05942456
Other study ID # PKUPH-sarcoma 16
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date June 5, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Peking University People's Hospital
Contact Lu Xie, M.D.
Phone +86-13401044719
Email xie.lu@hotmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Increasing data has indicated an association between increased soluble B7-H3 (sB7-H3) levels and unfavorable prognosis in patients with malignancies. However, the level of sB7-H3 and its clinical significance in osteosarcoma are not well known. In this present study, we investigated whether sB7-H3 levels in serum could be as a biomarker for osteosarcoma treatment.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date December 31, 2024
Est. primary completion date July 1, 2024
Accepts healthy volunteers No
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - High Grade osteosarcoma verified with pathologic diagnosis. - systemic treatment-naive before the first time Blood drawing. - ECOG 0 or 1 and all the other imagings indicate that patients could tolerate standard PKUPH-OS-02 protocol neoadjuvant chemotherapy. - All radiographs are complete for clinical evaluation. Exclusion Criteria: - Patients who Can't tolerate blood drawing. - Patients without complete medical records in PKUPH system. - Patients who can't tolerate PKUPH-OS-02 neoadjuvant chemotherapy. - other conditions that investigators think are not suitable for this study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
ELISA: enzyme-linked immunosorbent assay
enzyme-linked immunosorbent assay

Locations

Country Name City State
China Peking University People's Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

Wang L, Kang FB, Zhang GC, Wang J, Xie MF, Zhang YZ. Clinical significance of serum soluble B7-H3 in patients with osteosarcoma. Cancer Cell Int. 2018 Aug 13;18:115. doi: 10.1186/s12935-018-0614-z. eCollection 2018. — View Citation

Xie L, Chen C, Liang X, Xu J, Sun X, Sun K, Yang R, Tang X, Guo W. Expression and Clinical Significance of Various Checkpoint Molecules in Advanced Osteosarcoma: Possibilities for Novel Immunotherapy. Orthop Surg. 2023 Mar;15(3):829-838. doi: 10.1111/os.13620. Epub 2022 Dec 15. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary correlation of quantity of Protein B7-H3 Expression with clinical evaluation Clinical evaluation according to RECIST 1.1 6 months
Secondary correlation of quantity of Protein B7-H3 Expression with histological responses Histological responses according to Huvos Grade 6 months
Secondary correlation of quantity of Protein B7-H3 Expression with event-free survival event-free survival calculated from starting systemic therapy to any tumor-related events for progression 2 years
Secondary correlation of quantity of Protein B7-H3 Expression with overall survival overall survival calculated from starting systemic therapy to death 5 years
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